MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS; TORIC IOLS

Model Number	ZXT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2018 and (b)(6) 2018.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zct150 18.5 diopter lens was implanted in the patient's right eye (od) on (b)(6) 2018.Post-operatively on (b)(6) 2018, the patient complained of seeing rings and halos in the right eye at night when looking at oncoming traffic.Also, the distance vision corrected was 20/20, the near sighted vision corrected was j1+, and the auto refraction was -0.75 x +0.50 x 137.Post-operatively on (b)(6) 2018, the patient complained of blurry vision in the right eye, believes he has a foreign body in the right eye from yard work, and vitreous floaters in both eyes.Also, the distance vision corrected was 20/20 and the auto refraction was -0.25 x +0.75 x 152.It was later explanted on (b)(6) 2018.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Correction: in review, the initial emdr incorrectly reported the wrong model and catalog number.Therefore, an emdr correction is required to report the correct product which is a zxt225 21.5 diopter lens with serial number (b)(4).Also, the correct catalog number should be zxt225u215.Describe event or problem: the reported lens implanted in the patient''s operative eye was a zxt225 21.5 diopter lens.Model number: zxt225.Catalog number: zxt225u215.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7828610
• Report Number: 3011852734-2018-00154
• Device Sequence Number: 16596356
• Product Code: HQL
• UDI-Device Identifier: 05050474552111
• UDI-Public: (01)05050474552111(17)211104
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/04/2023
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U215
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/02/2018
• Supplement Date Received by Manufacturer: 09/18/2018; 10/25/2020
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 09/24/2018; 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005